Genomes and Genes
Summary: The use of humans as investigational subjects.
Publications230 found, 100 shown here
- Clinical outcome of experimental human malaria induced by Plasmodium falciparum-infected mosquitoesD F Verhage
Departments of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
Neth J Med 63:52-8. 2005..The objective of this study was to evaluate infection rates and clinical safety of different protocols for human experimental malaria induced by Plasmodium falciparum-infected mosquitoes...
- Safety and clinical outcome of experimental challenge of human volunteers with Plasmodium falciparum-infected mosquitoes: an updateJudith E Epstein
Malaria Program, Naval Medical Research Center, Silver Spring, MD, 20910, USA
J Infect Dis 196:145-54. 2007..In 1997, an analysis of experience with 118 volunteers indicated that mosquito inoculation of P. falciparum could be a safe, well-tolerated, reproducible, and efficient method of challenge...
- Informed consent and collaborative research: perspectives from the developing worldAdnan A Hyder
Dev World Bioeth 6:33-40. 2006..This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research...
- More than the money: a review of the literature examining healthy volunteer motivationsLeanne Stunkel
Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
Contemp Clin Trials 32:342-52. 2011..This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation...
- Beyond informed consentZulfiqar A Bhutta
Aga Khan University, Karachi 74800, Pakistan
Bull World Health Organ 82:771-7. 2004..Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings...
- The history of biological warfare. Human experimentation, modern nightmares and lone madmen in the twentieth centuryFriedrich Frischknecht
Friedrich Frischknecht is at the Malaria Biology and Genetics Unit, Department of Parasitology, Institut Pasteur, 25 28 Rue du Dr Roux, 75015 Paris, France
EMBO Rep 4:S47-52. 2003
- Balancing justice and autonomy in clinical research with healthy volunteersN E Kass
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Berman Institute of Bioethics, Baltimore, Maryland, USA
Clin Pharmacol Ther 82:219-27. 2007..Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology...
- Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelinesG B Tangwa
University of Yaounde, Cameroon
J Med Ethics 30:63-7. 2004....
- Therapeutic misconception in clinical research: frequency and risk factorsPaul S Appelbaum
Department of Psychiatry, University of Massachusetts Medical School, USA
IRB 26:1-8. 2004
- Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, TanzaniaEdith A M Tarimo
Division of Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden
PLoS ONE 6:e14619. 2011..The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled...
- Oversight of human participants research: identifying problems to evaluate reform proposalsEzekiel J Emanuel
Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
Ann Intern Med 141:282-91. 2004....
- Establishing risk of human experimentation with drugs: lessons from TGN1412M J H Kenter
Central Committee on Research Involving Human Subjects, The Hague, Netherlands
Lancet 368:1387-91. 2006
- Why healthy subjects volunteer for phase I studies and how they perceive their participation?Luis Almeida
Department of Research and Development, BIAL, A Av da Siderurgia Nacional, 4745 457, S Mamede do Coronado, Portugal
Eur J Clin Pharmacol 63:1085-94. 2007..To characterize the motivations and attitudes of healthy subjects who volunteer for phase I studies as well as their perception of the informed consent procedure and participation in the study...
- Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects researchHolly A Taylor
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
IRB 29:9-14. 2007
- After Helsinki: unresolved issues in international researchR Macklin
Albert Einstein College of Medicine, Bronx, New York, USA
Kennedy Inst Ethics J 11:17-36. 2001..An analysis of these current controversies reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles...
- Is the concept of informed consent applicable to clinical research involving critically ill patients?John M Luce
San Francisco General Hospital, CA, USA
Crit Care Med 31:S153-60. 2003..Stronger research oversight may be as important as informed consent in protecting patient welfare...
- Immunotherapy: bewitched, bothered, and bewildered no moreRalph M Steinman
Laboratory of Cellular Physiology and Immunology, Rockefeller University, New York, NY 10021 6399, USA
Science 305:197-200. 2004..We suggest steps to be taken to reinvigorate basic research in human subjects as part of the mainstream of science...
- Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injuryMichael K Paasche-Orlow
Department of Medicine, Boston University School of Medicine, Boston, Massachusetts 02118, USA
Am J Med 118:175-80. 2005..We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship...
- Ethics of medical research in developing countries: the role of international codes of conductJ L Hutton
Department of Statistics, University of Newcastle, Newcastle upon Tyne, UK
Stat Methods Med Res 9:185-206. 2000..Statisticians share important responsibilities in maintaining ethical medical research in all countries...
- Human experimentation in developing countries: improving international practices by identifying vulnerable populations and allocating fair benefitsKristen Farrell
University of Maryland School of Law, Baltimore, MD, USA
J Health Care Law Policy 9:136-61. 2006
- Ethical aspects in placental perfusion studies: views of the researchersA Halkoaho
University of Eastern Finland
Placenta 32:511-5. 2011..Thus, continuous effort for better research ethics is essential and requires research on research ethics...
- Views of midwives about ethical aspects of participation in placental perfusion studiesArja Halkoaho
Department of Nursing Science, Faculty of Health Sciences, University of Eastern Finland, 70211 Kuopio, Finland
Midwifery 28:131-7. 2012..Little is known regarding the role of the midwife in recruiting mothers to participate in scientific research...
- Clinical trials and healthy volunteersPamela R Ferguson
University of Dundee, Park Place, Dundee, UK
Med Law Rev 16:23-51. 2008
- [Regulations, conflicts and ethics of medical research in developing countries]Marta Maciel Lyra Cabral
Departmento de Imunologia, Fundacao Oswaldo Cruz, Recife, PE, Brasil
Rev Saude Publica 40:521-7. 2006..Therefore, it is necessary to minimize the risk of exploitation of developing countries populations. The present study provides an outlook of ethical protection for human research in developing countries...
- Conflicts of interest in research involving human beingsDirceu Greco
School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil
J Int Bioethique 19:143-54, 202-3. 2008....
- Paying research subjects: an analysis of current policiesNeal Dickert
W G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
Ann Intern Med 136:368-73. 2002..Few data are available on guidelines used by research organizations to make decisions about paying subjects...
- [Changes in the Declaration of Helsinki: economic fundamentalism, ethical imperialism and social control]V Garrafa
, , , , DF, 70910-900, Brasil
Cad Saude Publica 17:1489-96. 2001....
- Informed consent for pediatric research: is it really possible?Eric Kodish
J Pediatr 142:89-90. 2003
- Assessing benefits in clinical research: why diversity in benefit assessment can be riskyLarry R Churchill
Vanderbilt University, USA
IRB 25:1-8. 2003
- [Ethics and medical research: principles, guidelines, and regulations]Euclides Ayres de Castilho
Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de Sao Paulo, Av Dr Arnaldo 455, 01246 903 Sao Paulo, SP, Brazil
Rev Soc Bras Med Trop 38:344-7. 2005....
- Moral imperialism and multi-centric clinical trials in peripheral countriesVolnei Garrafa
Cátedra UNESCO de Bioética, Universidade de Brasilia, Brasilia, Brasil
Cad Saude Publica 24:2219-26. 2008....
- The age of neuroelectronicsAdam Keiper
The New Atlantis, USA
New Atlantis 11:4-41. 2006
- Experimental malaria in human volunteers: ethical aspectsH K A Visser
Neth J Med 63:41-2. 2005
- Justice and the human development approach to international researchAlex John London
Carnegie Mellon University, USA
Hastings Cent Rep 35:24-37. 2005
- Money for research participation: does in jeopardize informed consent?C Grady
National Institutes of Health, USA
Am J Bioeth 1:40-4. 2001..An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make...
- The role of community advisory boards: involving communities in the informed consent processR P Strauss
Department of Dental Ecology, School of Dentistry, University of North Carolina, Chapel Hill 27599 7450, USA
Am J Public Health 91:1938-43. 2001..These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question...
- Evaluation of the safety and immunogenicity of two antigen concentrations of the Mtb72F/AS02(A) candidate tuberculosis vaccine in purified protein derivative-negative adultsIsabel Leroux-Roels
Center for Vaccinology, Ghent University Hospital, De Pintelaan 185, B 9000 Ghent, Belgium
Clin Vaccine Immunol 17:1763-71. 2010..In conclusion, Mtb72F/AS02(A) is clinically well tolerated and is highly immunogenic in TB-naïve adults. The 10- and 40-μg Mtb72F/AS02(A) vaccines show comparable safety and immunogenicity profiles...
- Evaluating the quality of informed consentJeremy Sugarman
Phoebe R Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
Clin Trials 2:34-41. 2005..Having such means will be important to monitoring consent and testing potential improvements in the consent process...
- Early stage-specific immune responses in primary experimental human hookworm infectionStefan M Geiger
Fundacao Oswaldo Cruz, Centro de Pesquisas Rene Rachou, Avenida Augusto de Lima 1715, CEP 30190 002, Belo Horizonte MG, Brazil
Microbes Infect 10:1524-35. 2008..During reinfection studies in endemic areas, such distinct cytokine and chemokine profiles might be additional markers to better classify egg-negative patients...
- An assessment of early diagnosis and treatment of malaria by village health volunteers in the Lao PDRViengvaly Phommanivong
Institut de Francophonie pour Médecine Tropicale, Vientiane, BP 9519, Lao PDR
Malar J 9:347. 2010..Early diagnosis and treatment (EDAT) is crucial to reducing the burden of malaria in low-income countries. In the Lao PDR, this strategy was introduced in 2004-2005 and an assessment was performed at the community level in January 2007...
- Principal investigator views of the IRB systemSimon N Whitney
Department of Family, Community Medicine, Houston Center for Education, Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098 3926, USA
Int J Med Sci 5:68-72. 2008..Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits...
- Obtaining voluntary consent for research in desperately ill patientsCharles L Bosk
Department of Sociology, Center for Bioethics, Philadelphia, Pennsylvania, USA
Med Care 40:V64-8. 2002..This finding bypasses the careful weighing of risks and benefits that the model of informed consent is based upon. This paper explores how the requirements of candor need to be balanced with those of kindness...
- Ethics review for sale? Conflict of interest and commercial research review boardsT Lemmens
Faculty of Law, University of Toronto, 78 Queen s Park, Toronto, Ontario, Canada M5S 2C5
Milbank Q 78:547-84, iii-iv. 2000..The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process...
- International Genetic Epidemiology Society: commentary on Darkness in El Dorado by Patrick TierneyM P Baur
Department of Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany
Genet Epidemiol 21:81-104. 2001..Ethical issues about scientific research in primitive populations deserve serious and wide discussion, but the IGES condemns the gross misrepresentation of the facts and demonization of the principal characters in this book...
- Ethics. Protecting communities in biomedical researchC Weijer
Department of Bioethics, Dalhousie University, Halifax, Nova Scotia, B3H 4H7, Canada
Science 289:1142-4. 2000Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the ..
- Principles of early stopping of randomized trials for efficacy: a critique of equipoise and an alternative nonexploitation ethical frameworkDavid Buchanan
Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Kennedy Inst Ethics J 15:161-78. 2005....
- Ethics in international health research: a perspective from the developing worldZulfiqar Ahmed Bhutta
Department of Paediatrics, The Aga Khan University, Karachi, Pakistan
Bull World Health Organ 80:114-20. 2002..Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake...
- Research without consent: current status, 2003Michelle H Biros
Department of Emergency Medicine, Hennepin County Medical Center and the University of Minnesota School of Medicine, 701 Park Avenue South, Minneapolis, MN 55415, USA
Ann Emerg Med 42:550-64. 2003....
- Understanding of informed consent in a low-income setting: three case studies from the Kenyan CoastC S Molyneux
Kenya Medical Research Institute, PO Box 230, Kilifi, Kenya
Soc Sci Med 59:2547-59. 2004..These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere...
- The old faith and the new science: the Nuremberg Code and human experimentation ethics in Britain, 1946-73Jenny Hazelgrove
School of Nursing, University of Nottingham, UK
Soc Hist Med 15:109-35. 2002..In a similar move, their predecessors had helped to negotiate the Nuremberg Code in anticipation of public criticism of experimentation arising from the Nuremberg Medical Trial...
- The dysregulation of human subjects researchNorman Fost
JAMA 298:2196-8. 2007
- The therapeutic misconception: problems and solutionsCharles W Lidz
Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA
Med Care 40:V55-63. 2002..The therapeutic misconception is a serious problem for informed consent in clinical research...
- Reconstructing exposures from the UK chemical warfare agent human research programmeTj Keegan
Department of Public Health, University of Oxford, Oxford OX7 3LF, UK
Ann Occup Hyg 51:441-50. 2007..The resulting cohort study has the potential to provide information which will assist in understanding the long-term health impact of chemical warfare agent exposure on these veterans...
- Exposures recorded for participants in the UK Chemical Warfare Agent Human Research Programme, 1941-1989T J Keegan
Department of Public Health, University of Oxford, OX3 7LF, UK
Ann Occup Hyg 53:83-97. 2009..The study is part of a programme of epidemiological research initiated in response to service veterans' concerns about possible long-term health effects of their participation...
- Human hallucinogen research: guidelines for safetyMw Johnson
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA
J Psychopharmacol 22:603-20. 2008..Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science...
- Identification of Haemophilus ducreyi genes expressed during human infectionMargaret E Bauer
Department of Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN 46202, USA
Microbiology 154:1152-60. 2008..We identified three genes, lspA1, lspA2 and tadA, known to be required for virulence in humans. This is the first study to broadly define transcripts expressed by H. ducreyi in humans...
- Human testing of pesticides: ethical and scientific considerationsAlan H Lockwood
Center for PET 115P, VA Western NY Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215, USA
Am J Public Health 94:1908-16. 2004..An EPA committee that is free from political and financial conflicts of interest should review this practice...
- Pesticide testing in humans: ethics and public policyChristopher Oleskey
Center for Children s Health and the Environment, Box 1043, Mount Sinai School of Medicine, One Gustav L Levy Place, New York, NY 10029, USA
Environ Health Perspect 112:914-9. 2004..Participants also strongly encouraged active biomonitoring of every pesticide currently in use to track human exposure, particularly in vulnerable populations, and to assess adverse effects on health...
- Recommendations for informed consent forms for critical care clinical trialsHenry J Silverman
University of Maryland School of Medicine, Baltimore, MD, USA
Crit Care Med 33:867-82. 2005..Many subjects enrolled in research studies have a limited understanding of the research to which they consented...
- Is the argument from marginal cases obtuse?Daniel A Dombrowski
Seattle University, Seattle, WA 98122, USA
J Appl Philos 23:223-32. 2006..The purpose of the present article is to argue that, despite Anderson's and Diamond's nuanced and perceptive treatments of the argument from marginal cases, this argument is not obtuse in either sense of the term...
- The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?Hazel Glenn Beh
William S Richardson School of Law, University of Hawaii, USA
Law Psychol Rev 26:1-47. 2002
- Challenges of ethical research in resource-poor settingsB M Dickens
Faculty of Law, University of Toronto, Toronto, Ontario, Canada
Int J Gynaecol Obstet 80:79-86. 2003..The structure and functions of research ethics review committees present difficult challenges, but they may be mitigated by enlightened international collaboration...
- Research ethics and law of healthcare system quality improvement: the conflict of cost containment and qualityW Andrew Kofke
Department of Anesthesia, University of Pennsylvania, Philadelphia 19104 4283, USA
Crit Care Med 31:S143-52. 2003..The ethical and legal foundations exist to support the systematic practice of informing patients of their participation in some types of QI procedures...
- Vulnerability to influence: a two-way streetGail E Henderson
University of North Carolina School of Medicine, USA
Am J Bioeth 4:50-2; discussion W32. 2004
- Research on the socio-ethical impact of biomarker use and the communication processes in ECNIS NoE and NewGeneris IPBirgit Dumez
Center for Human Genetics, Department of Medicine, University of Leuven, Herestraat 49, 3000 Leuven, Belgium
Int J Hyg Environ Health 210:263-5. 2007..A harmonized socio-ethical and legal approach not only increases the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of each citizen of the European Union...
- Human subjects issues and IRB review in practice-based researchLeslie E Wolf
University of California, San Francisco, San Francisco, California 94143 0903, USA
Ann Fam Med 3:S30-7. 2005..This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research...
- Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudesAngelique M Reitsma
Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908 0758, USA
J Am Coll Surg 200:103-10. 2005..Surgeons were also invited to self-report knowledge about current federal regulations guiding human subject research and rules for informed consent for and IRB review of clinical research...
- Human experimentation: a rule gone awry?Adrian Burton
Environ Health Perspect 114:A360-2. 2006
- Bench-to-bedside review: human subjects research--are more standards needed?David T Huang
CRISMA Laboratory, Department of Critical Care Medicine, Department of Emergency Medicine, University of Pittsburgh, 641 Scaife Hall, Pittsburgh, PA 15261, USA
Crit Care 10:244. 2006..We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine...
- Ethical review of health research: a perspective from developing country researchersA A Hyder
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
J Med Ethics 30:68-72. 2004....
- Rationalizing risk assessment in human subject researchCarl H Coleman
Health Law and Policy Program, Seton Hall Law School, USA
Ariz Law Rev 46:1-51. 2004
- Are the rules for research with subjects with dementia changing?: views from the fieldCarol B Stocking
Section of Geriatrics, MacLean Center for Clinical Medical Ethics, Department of Medicine, University of Chicago, IL 60637, USA
Neurology 61:1649-51. 2003..The real tradeoff between protection and difficulty in conducting research on devastating illnesses needs to be confronted when new regulations in this area are debated...
- Human experimentation with Neisseria gonorrhoeae: progress and goalsM S Cohen
Department of Medicine, University of North Carolina at Chapel Hill 27599 7030, USA
J Infect Dis 179:S375-9. 1999..The experimental model has proven to be an efficient means of studying gonococcal infection and focusing vaccine development. In addition, this model should allow vaccines to be tested quickly and efficiently...
- Regional ethics organizations for protection of human research participantsAnne Wood
School of Law, University of California, Berkeley, Berkeley, California 94720 7200, USA
Nat Med 10:1283-8. 2004
- Ethics review procedures for research in developing countries: a basic presumption of guiltRobert H Gilman
Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, USA
CMAJ 171:248-9. 2004
- Should society allow research ethics boards to be run as for-profit enterprises?Ezekiel J Emanuel
Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, United States
PLoS Med 3:e309. 2006..Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval...
- What is a "minor" increase over minimal risk?David Wendler
Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
J Pediatr 147:575-8. 2005
- Educating researchers: ethics and the protection of human research participantsJulie Rothstein Rosenbaum
Yale University School of Medicine, New Haven, CT, USA
Crit Care Med 31:S161-6. 2003....
- The case of Chester M. Southam: research ethics and the limits of professional responsibilityBeth Aviva Preminger
Cornell University Joan and Sanford I Weill Medical College, USA
Pharos Alpha Omega Alpha Honor Med Soc 65:4-9. 2002
- Research firm changes subject notification procedure after complaint by potential subjectDennis M Maloney
The Deem Corporation, P O Box 44069, Omaha, NE 68144, USA
Hum Res Rep 17:6-7. 2002
- Undue inducement: the only objection to payment?Ari VanderWalde
Am J Bioeth 5:25-7. 2005
- A quartet of criticismsHarold Y Vanderpool
University of Texas Medical Branch, USA
Am J Bioeth 5:16-9. 2005
- Undue inducement: nonsense on stilts?Ezekiel J Emanuel
National Institutes of Health, USA
Am J Bioeth 5:9-13; discussion W8-11, W17. 2005
- Institutional review boards and the privacy of human research subjectsDennis M Maloney
The Deem Corporation, P O Box 44069, Omaha, NE 68144, USA
Hum Res Rep 17:1-2. 2002
- The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countriesSomei Kojima
Asian Center of International Parasite Control, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
Southeast Asian J Trop Med Public Health 36:728-32. 2005..This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome...
- Clinical trials face heightened scrutiny as science and commerce appear to mergeAlvin J Lorman
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, USA
J Biolaw Bus 4:23-32. 2001..The risk of increased government involvement includes criminal prosecution of physicians for failing to follow the rules, as an innovative case in California demonstrates...
- Beginning anew: same principles, different direction for research ethicsMary Simmerling
University of Chicago, USA
Am J Bioeth 5:44-6; author reply W15-8. 2005
- Research versus innovation: real differencesHaavi Morreim
University of Tennessee Health Science Center, USA
Am J Bioeth 5:42-3; author reply W15-8. 2005
- Does research ethics rest on a mistake? The common good, reasonable risk and social justiceAlex John London
Carnegie Mellon University
Am J Bioeth 5:37-9; author reply W15-8. 2005
- Does research ethics rest on a mistake?Franklin G Miller
Department of Clinical Bioethics, National Institutes of Health, USA
Am J Bioeth 5:34-6; author reply W15-8. 2005
- How not to rethink research ethicsTom L Beauchamp
Georgetown University, USA
Am J Bioeth 5:31-3; author reply W15-8. 2005
- Some questionable premises about research ethicsRuth Macklin
Albert Einstein College of Medicine, USA
Am J Bioeth 5:29-31; author reply W15-8. 2005
- Rethinking research ethicsRosamond Rhodes
Mount Sinai School of Medicine
Am J Bioeth 5:7-28. 2005..These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research...
- Reflections on 'Rethinking research ethics'Robert J Levine
Am J Bioeth 5:1-3; author reply W15-8. 2005
- Response to Athula Sumathipala and Sisira Siribaddana, "Revisiting 'freely given informed consent' in relation to the developing world: the role of an Ombudsman" (AJOB 4:3)Bob Simpson
Am J Bioeth 5:W24-6. 2005
- The limitations of "vulnerability" as a protection for human research participantsCarol Levine
United Hospital Fund
Am J Bioeth 4:44-9. 2004..Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges...
- A plea for pragmatism in clinical research ethicsDavid H Brendel
Harvard Medical School, McLean Hospital, Belmont, MA 02478, USA
Am J Bioeth 8:24-31. 2008....
- Part I: what is the requirement for data sharing?Virginia A de Wolf
IRB 27:12-6. 2005
- Strangers at the benchside: research ethics consultationMildred K Cho
Stanford Center for Biomedical Ethics, Center for Integration of Research on Geneticsand Ethics, Palo Alto, CA 94304, USA
Am J Bioeth 8:4-13. 2008..We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program...
- [Clinical trials in developing countries: who should define ethics?]F Béréterbide
Faculte de Medecine, Département de recherche éthique, Universite Paris Sud XI, France
Bull Soc Pathol Exot 101:102-5. 2008....
- Recombinant Attenuated Salmonella Vaccines for HumansRoy Curtiss; Fiscal Year: 2012..We will also develop a RASV using S. Typhi as vector to prevent transmission and infection by Mycobacterium tuberculosis. ..
- MOUSE MODEL FOR DISEASES OF PROTEIN MISFOLDINGP Michael Conn; Fiscal Year: 2012..A convenient laboratory model for these diseases is needed if the use of pharmacoperones is to translate to human well-being, since US law requires animal testing prior to normal human volunteers. ..
- Neuroendocrine Response to Gastric Bypass in Nonhuman PrimatesRandy J Seeley; Fiscal Year: 2010..humans directly;however, many experiments require interventions or assessments that are too invasive for human experimentation. For such studies, examination of nonhuman primates (NHPs) provides an attractive alternative...
- Bifunctional Redox Catalyst &Organic Nitrate for Limb ReperfusionANDREW LURIE SALZMAN; Fiscal Year: 2013..IV dose range-finding and 2 week repeat-dose toxicology studies in rats and dogs, with associated toxicokinetic determinations. ..
- Dietary HDAC Inhibitors in Colon Cancer PreventionRoderick H Dashwood; Fiscal Year: 2012....
- Inhibition of Carboxylesterase Metabolism by EthanolRobert B Parker; Fiscal Year: 2011..Understanding this interaction is a necessary component for the safe and effective use of drugs metabolized by carboxylesterases. ! ..
- Harmful effects of transfusion of older stored red cells: iron and inflammationSteven L Spitalnik; Fiscal Year: 2012....
- Syk blockade in bullous skin diseasesUma Sinha; Fiscal Year: 2012..In this Phase I program we will provide proof-of-concept for Syk inhibitors in BP using both animal models and relevant ex vivo human biospecimens. ..
- The Role of Protein Kinase D in Epidermal TumorigenesisWendy B Bollag; Fiscal Year: 2013..Evidence concerning the role of PKD in the keratinocyte response to UVB may be important for predicting possible sun sensitivity in patients undergoing systemic chemotherapy with PKD inhibitors. ..
- MOLECULAR REGULATION OF MUSCLE GLUCOSE METABOLISM IN MANLawrence J Mandarino; Fiscal Year: 2013..Protein targets for this aim will be prioritized based on the potential role of the protein in insulin resistance or mitochondrial function as well as dysregulation of its acetylation state in insulin resistant muscle. ..
- Detection of Brown Adipose Tissue Using Contrast UltrasoundMarielle Scherrer-Crosbie; Fiscal Year: 2012..If the proposal is successful, CEU may be a non irradiating, widely available technique to detect BAT and monitor potential therapies that increase functional BAT. ..
- Chronic DTH and IFN-gamma in Human Graft ArteriosclerosisJordan S Pober; Fiscal Year: 2010....
- Comparative Mechanisms of Cancer ChemopreventionRoderick H Dashwood; Fiscal Year: 2013..This application is innovative and timely in bridging basic mechanisms, preclinical models, and human studies of epigenetics and diet. ..
- Imaging Cytolytic T Cells in Cancer Patients Using PET Reporter Genes/Reporter PrSanjiv S Gambhir; Fiscal Year: 2012..Here, we propose non-invasive imaging of therapeutic immune cells that will be infused into patients with glioma brain tumors and have been shown to kill glioma brain tumor cells. ..
- Intracavitary Hemostatic Agent for Non-compressible HemorrhageMartin Bluth; Fiscal Year: 2007..This therapeutic approach will reduce killed in action (KIA) rate, increased life saving capability for the medic, and reduce need for surgery and transfusion. [unreadable] [unreadable] [unreadable]..
- MONOAMINE AND HALLUCINOGEN EFFECTS ON RODENT BEHAVIORMark A Geyer; Fiscal Year: 2013..PUBLIC HEALTH RELEVANCE: Despite hundreds of years of human experimentation and recent increases in the use of hallucinogens either as religious sacraments or as "Club Drugs" in ..
- PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONSStanley M Spinola; Fiscal Year: 2013..Chancroid can be treated with only three types of antibiotics. The genes controlled by the stress response systems may prove to be targets of vaccines or alternative treatments for H. ducreyi infection. ..
- Mechanisms of Altered Skin Re-Epithelialization in AgingLaure Rittie; Fiscal Year: 2013....
- Influence of Gonadal Hormones on Fear ExtinctionMohammed R Milad; Fiscal Year: 2010..This proposal will also examine the influence of progesterone administration on boosting the brain's signal for safety. Findings from this proposal may help the development of sex-specific treatments for anxiety disorders...
- Genome-wide genetic variation in the human immune response to influenza vaccinesLUIS MIGUEL FRANCO; Fiscal Year: 2013..The results of this research will help in the development of better vaccines and allow healthcare practitioners to use a more personalized approach to vaccination. ..
- Training and research application for c-spine ultrasound of an aging population.DANIEL BUCKLAND; Fiscal Year: 2013....
- The Impact of Tobacco Exposure on the Lungs Innate Defense SystemRobert Tarran; Fiscal Year: 2013..Such knowledge may help dispel the myth that new tobacco products represent a safer alternative to cigarettes. ..
- Thalamic Visual ProsthesisJohn S Pezaris; Fiscal Year: 2013..As proposed here, an important step in making a device like that is to understand how complicated it needs to be in order to be useful and to test a prototype in an animal model. ..
- Optimization of HIV vaccines for the induction of cross-reactive antibodiesShan Lu; Fiscal Year: 2013..RELEVANCE: To optimize the next generation polyvalent Env HIV vaccine formulations using the multi-gene, polyvalent DNA prime - protein boost technology platform. ..
- An ACE Inhibitor as a Treatment for Methamphetamine DependenceTHOMAS FREDERICK NEWTON; Fiscal Year: 2012..A separate human laboratory study will examine the dose-dependent effects of perindopril on MA- induced craving, though these participants will not take part in the clinical trial. ..
- Interactive MR Image Guided Intervention (iMR-IGI) for Breast ApplicationsMICHAEL ROY ZINN; Fiscal Year: 2012..In time, additional benefits could include less aggressive recommendations for MRI detected lesions and, more importantly, a paradigm shift for breast cancer detection, diagnosis and treatment in general. ..
- Clinical Development of 4-Cl-KYN to Treat PainRALPH SNODGRASS; Fiscal Year: 2010..Positive results from this study will serve as a basis for further development of AV-101 in Phase II trials for treatment of neuropathic pain. ..
- LC-MS Analysis of DNA Adducts of Aromatic Amines: Relationship to Bladder CancerPaul Vouros; Fiscal Year: 2013..abstract_text> ..
- Free-Breathing Perfusion MRI of the Abdomen with Predictive Motion CorrectionH Michael Gach; Fiscal Year: 2013..The technique may be further developed for other anatomical regions of interest or applications where physiological motion impedes accurate diagnosis or therapy (e.g., radiotherapy). ..
- An interdisciplinary approach to elucidate mechanisms of muscle lipotoxicityGREGORY PAUL ROTH; Fiscal Year: 2011..abstract_text> ..
- Endothelial Progenitor Cells in Diabetes and Renal FailureKaren A Lapidos; Fiscal Year: 2010..In the current investigation, EPCs from patients with diabetes and kidney failure will be examined to determine their suitability for such cell based-therapies. ..
- Licit Abused DrugsRoland R Griffiths; Fiscal Year: 2013..The project will provide information about pharmacological, behavioral and genetic determinants of vulnerability to substance abuse, with important substance abuse prevention, treatment, and public education implications. ..
- Genetically Attenuated Malaria Attenuated Whole Parasite Sporozoite VaccineSTEPHEN LEV HOFFMAN; Fiscal Year: 2012..The PfSPZ Vaccine is attenuated (weakened) by irradiation of each vaccine lot. This research aims to eliminate the need for irradiation in manufacturing a PfSPZ vaccine, by creating parasites that are attenuated by gene removal. ..
- Mechanical Airway Support Device to Treat Obstructive Sleep Disordered BreathingPhilip M Wong; Fiscal Year: 2013..The investigative team, with demonstrated expertise in respiratory biomedical innovation, sleep medicine, and commercialization, is ideally positioned to execute this project successfully. ..
- Neuropharmacology of Tramadol: Clinical Efficacy and Abuse PotentialWILLIAM WALTON STOOPS; Fiscal Year: 2010..Developing analgesics with reduced abuse potential may reduce the prevalence of prescription opioid misuse and subsequent opioid use disorders. ..
- Merging Diffuse Optical Tomography with EEG, MEG and MRI for Neurovascular ExamsSolomon Gilbert Diamond; Fiscal Year: 2010..Research on the neurovascular relationship will ultimately have long-term benefits to understanding the aging brain and diagnosing neurological diseases. ..
- Preparation and Distribution of Adult Stem CellsDARWIN JOHNSON PROCKOP; Fiscal Year: 2013..We will provide assistance from a collaborating expert in bioinformatics in evaluating the data. ..
- RESEARCH PROJECT 1James L Howard; Fiscal Year: 2011..Information from all the studies will be used for prioritization of compounds to be submitted for toxicological evaluation by NIDA and final selection of a back-up compound. ..
- The genetic basis of impulsive behavior in humansHarriet de Wit; Fiscal Year: 2013..The study is innovative because it combines rigorous behavioral analysis with multi-level genetic analysis. ..
- Lysolipid Signaling in Cardiovascular DiseaseSusan S Smyth; Fiscal Year: 2013..Completion of these studies promises to provide valuable insight into regulation of platelet function and may have exciting implications for the development of novel anti-thrombotic strategies that target LPA signaling. ..
- Induction of Immunity in Human Genital Tract: Effect of Intranasal ImmunizationZina Moldoveanu; Fiscal Year: 2010..The results obtained will be important for the design of immunization strategies to prevent infections with agents of sexually transmitted diseases. ..
- Chloroquine Sensitive Plasmodium falciparum for MultiValent Vaccine &ChallengeSTEPHEN LEV HOFFMAN; Fiscal Year: 2013....
- Clinical Pharmacology/Mechanisms of Action of Emerging Abused Drugs (Club Drugs)Roland R Griffiths; Fiscal Year: 2013....
- Attenuated Live and Recombinant Yersinia pestis VaccinesRoy Curtiss; Fiscal Year: 2013..We will provide research support during the proposed clinical trials. ..
- Systems genetic analysis of methamphetamine's motivational effects in a mouse AILAbraham A Palmer; Fiscal Year: 2013..Identification of these genes may be useful for developing new therapeutic strategies to treat or prevent drug abuse and addiction. ..
- The endothelium and resistance to rickettsial infectionGustavo Valbuena; Fiscal Year: 2012..The innovation of our research lays in bridging the gap between animal and human experimentation by implementing novel in vivo physiological experimental systems of the human endothelium and our ability ..
- Heat Effect on Generic Transdermal Drug Delivery SystemsAudra L Stinchcomb; Fiscal Year: 2013..Future years of this project could include examination of the heat effect on additional drug patches, on special patient populations, and on skin with compromised barrier. ..
- Source-Filter Interaction in SpeechIngo R Titze; Fiscal Year: 2013..Human volunteers and computer simulation will be used in a structured way to quantify and explain the nature of SFI. ..
- An NMDA Glycine Site Antagonist for the Treatment of Major Depressive DisorderRobert Schwarcz; Fiscal Year: 2013....
- Quantification of breast density using dual energy mammographySabee Molloi; Fiscal Year: 2013..The long-range plan for this project is to develop a clinically feasible method to measure the density of a woman's breast with dual energy x-ray mammography. ..
- Clinical and Preclinical Models in Drug Abuse: Training and DevelopmentRichard W Foltin; Fiscal Year: 2013..This model has worked well in the past and will be used to develop new K awards for junior faculty. ..
- Lyophilization of Plasmodium falciparum sporozoite vaccineStephen Hoffman; Fiscal Year: 2007..Additionally, a dried vaccine may accelerate a concerted world-wide effort to eradicate this devastating disease. [unreadable] [unreadable] [unreadable]..
- A preclinical assessment of monthly intramuscular GSK1265744, an InSTI, as PrEPMARTIN H MARKOWITZ; Fiscal Year: 2013....
- MicroRNA and protein profiling in melanocytes exposed to solar UVR in situMLNIKKI L HARTER; Fiscal Year: 2013..b) Use this new class of proteomic profiling technology to analyze the potentially altered state of molecular pathways relevant to the early development of melanoma. ..
- Race and Human Experimentation in the Eighteenth-Century Atlantic WorldLonda Schiebinger; Fiscal Year: 2013..the eighteenth-century Atlantic world, exploring how newly developing concepts of race and sex figured in human experimentation. Specifically, this research analyzes how human subjects were chosen for experiments, and how notions of ..
- Diffusion MRI of Complex White Matter and ConnectivityVan J Wedeen; Fiscal Year: 2013....
- PARP inhibitor therapy for septic shockAndrew Salzman; Fiscal Year: 2004..Based on pre-clinical porcine shock models and clinical safety studies, we expect INO-1001 to be a safe, well-tolerated and effective therapeutic in patients with septic shock. ..
- Characterizing habitual and goal-directed behavioral control systems in the humanJOHN P O'DOHERTY; Fiscal Year: 2013..Ultimately this research has the potential to lead to the development of new mechanisms for inducing habitual control in order to achieve the maintenance of adaptive and healthful behaviors. ..
- HIV-Specific B Cell Repertoire in Humans Following Cross-Clade ImmunizationPaul W Spearman; Fiscal Year: 2013..These data will provide important new information that will inform the design of HIV vaccine regimens designed to elicit broadly- neutralizing antibodies. ..
- N-acetylcysteine as a Potential Treatment for Methamphetamine DependenceTHOMAS FREDERICK NEWTON; Fiscal Year: 2010....
- Ventilation Stethoscope using Hyperpolarized XenonSamuel Patz; Fiscal Year: 2013..With this device, we propose to demonstrate the measurement of regional ventilation in healthy adult human volunteers. ..
- A handheld scanner for clinical oximetryPeriannan Kuppusamy; Fiscal Year: 2013....
- Multi-view, Photon Counting DXA Scanner for Quantitative Musculoskeletal ImagingThomas J Beck; Fiscal Year: 2011..If successful a scanner capable of scanning patients either erect or recumbent will be built in Phase 2 and tested on human volunteers. ..
- Improving Production of Attenuated Malaria Sporozoite Vaccines through Genetic MoPeter Billingsley; Fiscal Year: 2009..Success in this project will significantly decrease the cost of development and production of the vaccine, and reduce the time to market for this malaria vaccine. ..
- Resistant E.coli in Humans and PoultryJames Johnson; Fiscal Year: 2005..Does the research address a current and compelling problem of antimicrobial resistance that is of high public health importance and for which research is needed? [yes]. ..
- MARKERS OF HUMAN INFECTION WITH BOVINE LEUKEMIA VIRUSGERTRUDE BUEHRING; Fiscal Year: 2007..unreadable] [unreadable] [unreadable]..
- IMMUNOCHEMISTRY OF GONOCOCCAL LIPOPOLYSACCHARIDEJOHN GRIFFISS; Fiscal Year: 2003..Gonococci shed during gonorrhoea make larger LOS. The higher Mr LOS made by MS11mkC - a strain used in human experimentation -have polylactosamine structures...
- LUNG SURFACE ANTIOXIDANT DEFENSES AGAINST AIR POLLUTANTSCARROLL CROSS; Fiscal Year: 2000..This information is likely to increase our understanding of lung injury due to inhalation of air pollutants, and will enable development of strategies to prevent lung injury by inhaled oxidants. ..
- Potency of cryopreserved, irradiated sporozoite vaccineStephen Hoffman; Fiscal Year: 2005..The project will also provide a method for cryopreserving unirradiated sporozoites that could be used to challenge volunteers by injection with P. falciparum in vaccine studies worldwide. ..
- AGING EFFECT ON DRUG BIOAVAILABILITYStephen Hall; Fiscal Year: 1999..However, the choice of model compounds will also provide a general understanding of the mechanism of interactions between CYP3A substrates and the modulation of these interactions by advanced age. ..
- Gene-engineered dendritic cell therapy for diabeticsMassimo Trucco; Fiscal Year: 2003..The ultimate result could include less intensive or even a complete cessation of insulin replacement therapy in newly-diagnosed diabetics as well as, perhaps, a means of preventing diabetes. ..
- Gene-engineered dendritic cell therapy for diabeticsMassimo Trucco; Fiscal Year: 2006..The ultimate result could include less intensive or even a complete cessation of insulin replacement therapy in newly-diagnosed diabetics as well as, perhaps, a means of preventing diabetes. ..
- Inhalation Dosimetry/Exposure Index of Fiber AerosolYung Sung Cheng; Fiscal Year: 2006..Sampling devices based on this size-selection definition can be developed in the future for improved assessment of worker exposure. ..
- SEVERE PERIODONTITIS AS A RHEOLOGIC MODIFIERSTEVEN ENGEBRETSON; Fiscal Year: 2003..Dr. Engebretson will receive training in research methodology and molecular biology in order to explore the mechanisms of periodontal medicine through the conduct of human clinical studies as a career goal. ..
- Translation Research in Plasmodium vivaxSocrates Herrera; Fiscal Year: 2005..abstract_text> ..
- DUODENOGASTRIC REFLUX IN HEALTH AND DISEASERonald Hinder; Fiscal Year: 1991..The results of this project will provide a better understanding of the phenomenon of DGR, more definitive diagnosis of pathologic DGR, and will explore the physiological advantages of a new surgical therapy...
- PH CONTROL OF PROTEIN SYNTHESISPeter Garlick; Fiscal Year: 2003..abstract_text> ..